A First-in-human Study to Assess OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

Launched by EMERCELL SAS · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called OT-C001 for people with a type of blood cancer known as diffuse large B-cell lymphoma (DLBCL) that has come back or hasn’t responded to previous treatments. The main goal is to find out if OT-C001 is safe to use and to figure out the best dose for patients. The study will also look at how well the treatment works in these patients.

If you join this study, you will first receive a short course of chemotherapy to prepare your body. Then, you’ll get weekly doses of OT-C001 for either 3 or 6 weeks. Along with OT-C001, you will also receive two other medicines, rituximab and IL-2, which help support the treatment. You will need to visit the clinic regularly and might stay in the hospital depending on the study plan. To be eligible, you must be an adult with confirmed DLBCL that has returned or not responded to treatment, and you should be well enough to take part, with no serious other health issues that could interfere. This study is currently recruiting patients, so if you or a loved one fits this description, it might be an option to discuss with your doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥18 years of age
• • histologically confirmed diagnosis of R/R DLBCL-NOS without further standard treatment options including those relapsing after or ineligible for CAR T-cell therapy
• • with evaluable disease
• • with adequate biological parameters at baseline
• • ECOG performance status ≤1
• • life expectancy \>3 months as assessed by the investigator
• Exclusion Criteria:
• • Receive concomitantly any antitumor-directed drug therapy
• • Any vaccination with live virus vaccines before or during treatment
• • With severe atopic predisposition who need a treatment with monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids
• • Major surgery within 3 weeks
• • With rapidly progressing disease that includes massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, and over 50% liver involvement
• • Ongoing immune-related tocivities or adverse events grade \>1 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
• • Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
• • Primary or secondary immune deficiency
• • Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
• • Seropositive (except after vaccination or confirmed cure for hepatitis) for HIV, HBV, or HCV
• • Clinically significant cardiac disease including heart failure, uncontrolled hypertension, pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 12 months
• • Dementia or altered mental status that would prohibit informed consent
• • Other malignancy within the last 3 years except adequately treated nonmelanoma skin cancer, in situ carcinoma of the uterine cervix, or myelodysplastic syndromes